| Objective : To compare the clinical efficacy and safety of Diabetic macular edema granules combined with anti-vascular Endothelial Growth Factor(VEGF)in the treatment of Diabetic macular edema(DME).Methods: A total of 70patients(70eyes)who were initially diagnosed as DME by FFA and OCT in the Department of Ophthalmology,Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from December 2019 to December 2020 were collected and divided into combined group and single group.35 patients(35eyes)were treated with diabetic retinopathy macular edema granules(oral,4 weeks/course,a total of 3 courses)combined with anti-VEGF 3+PRN combined with anti-VEGF 3+PRN,and 35patients(35eyes)were treated with anti-VEGF 3+PRN alone.The best corrected visual acuity(BCVA),central macular thickness(CMT),TCM syndrome score,medicine injection times and ophthalmological and systemic adverse reactions were measured before and at 1,3 and 6months after treatment.SPSS 22.0 statistical software was used for statistical analysis.Results:1.Best Corrected Visual Acuity(BCVA)(1)BCVA in both groups at 1,3 and 6 months of treatment was significantly higher than that before treatment,and the differences at each follow-up time point in the combined group were statistically significant(P<0.05).There was statistically significant difference in the single group at 1 and 3 months after treatment(P<0.05),while there was no statistically significant difference at 6 months after treatment(P>0.05).(2)Before treatment and 1 month of treatment,there was no statistically significant difference in BCVA between the two groups(P>0.05),and there was statistically significant difference between 3 and 6 months of treatment(P<0.05).The improvement of visual acuity in the combined group was significantly better than that in the single group.The total effective rates of the combined group were 93.5%,93.5% and 74.2% at the 1,3 and 6 months of treatment,and those of the single group were 90.6%,84.4% and 40.6%,respectively.There was no statistical significance in the difference at the 1 month of treatment(P>0.05).The effective rates of the combined group at the 3 and 6 months of treatment were significantly higher than those of the single group,with statistical significance(P<0.05).2.Central Macula Thickness(CMT)(1)Compared with before treatment,CMT was significantly decreased in both groups at 1,3 and 6 months after treatment,and the differences within groups were statistically significant(P<0.05).(2)There was no statistical difference in CMT between the two groups before and after 1 month of treatment(P>0.05).The CMT of the combined group at 3 and 6months of treatment was lower than that of the single group,and the difference was statistically significant(P<0.05).The total effective rate of the combined group was 48.4%,96.8% and 83.9% at 1,3 and 6 months,and that of the single group was 34.4%,65.6% and46.9%,respectively.There was no statistical significance in the comparison of the 1 month of treatment(P>0.05).The effective rate of the combined group at 3 and 6 months was significantly higher than that of the single group,with statistical significance(P<0.05).3.TCM syndrome scoring:(1)The scores of TCM syndromes in the 1,3 and 6 months of treatment decreased in both groups compared with those before treatment,and the decrease was more obvious in the combined group,with statistical significance in intra-group comparison(P<0.05).(2)There was no statistical difference in syndrome scores between the two groups before treatment and 1 month after treatment(P>0.05),and syndrome scores in the combined group were significantly lower than those in the single group at 3 and 6 months after treatment,with statistical significance(P<0.05).The total effective rates of the combined group were16.13%,77.5% and 54.8% after 1,3 and 6 months of treatment,respectively,which were higher than those of the single group(6.25%,43.8% and 21.9%).There was no statistical significance in the comparison of 1 month of treatment(P>0.05),but there was statistical significance in the comparison of 3 and 6 months of treatment(P<0.05).The difference of TCM syndrome scores between the combined group before treatment and 6 months after treatment was 7.74±4.52 points,which was significantly higher than that of the single group(2.66±4.45 points),with statistical significance(P<0.05).4.Number of injectionsFrom the beginning of treatment to the end of follow-up,the total times of drug injection in the combined group were 103 times(3.32±0.54 times on average),which were all lower than that in the single group(113 times,3.53±0.67 times on average).There was no statistical significance between the two groups(P>0.05).5.Safety evaluation:(1)Up to the end of follow-up,there were 3 cases of subconjunctival hemorrhage and1 case of elevated intraocular pressure.One case of increased intraocular pressure was transient and relieved spontaneously after observation;three cases of subconjunctival hemorrhage were not treated and absorbed spontaneously after 1 week,which was considered to be related to the injection process rather than the drug.No ocular complications such as corneal epithelial defect and infectious endophthalmitis occurred in both groups.(2)There were no systemic adverse reactions,such as vomiting,diarrhea,rash,cardiovascular and cerebrovascular accidents,in both groups.Conclusion:1.Both anti-VEGF combined with diabetic macular edema granules and anti-VEGF alone are effective methods for the treatment of DME,which can effectively reduce the thickness of macular thickness,improve visual acuity,and reduce TCM syndrome score.2.The combination group has obvious advantages in improving patients’ visual acuity,alleviating macular edema and improving systemic accompanying symptoms,which can provide certain clinical basis and research ideas for the treatment of DME with integrated traditional Chinese and western medicine. |
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